Vacuum expanded dry composition and syringe for retaining same
Inventors
Larsen, Kristian • Mortensen, Michael Wrang
Assignees
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Publication Number
US-10595837-B2
Publication Date
2020-03-24
Expiration Date
Abstract
The present disclosure relates to a method for vacuum expansion of a paste prior to freeze-drying said paste to achieve a dry paste composition which reconstitutes efficiently to form a flowable paste upon addition of an aqueous medium. The present disclosure further relates to a syringe for retaining a dry paste composition in a vacuum.
Core Innovation
The invention provides a dry composition suitable for use in haemostasis and wound healing. The dry composition comprises a vacuum-expanded paste having entrapped gas therein, which is subsequently frozen and then freeze-dried. The resulting dry composition spontaneously reconstitutes into a paste upon contact with an aqueous medium, without mechanical mixing or agitation.
The core technical concept is the formation of a vacuum-expanded, gas-entrapped paste structure that is then frozen and freeze-dried to yield a stable dry composition. Vacuum expansion is described as reducing reconstitution time compared with standard lyophilization, and reconstitution is described as occurring within seconds in the provided context.
The disclosure further associates the dry vacuum-expanded freeze-dried paste with haemostatic and wound-healing functionality and allows inclusion of bioactive agents. The composition can include cross-linked biocompatible polymers such as gelatine, hydrophilic compounds including polyols or sugar alcohols such as mannitol and PEG, and bioactive agents such as thrombin.
Claims Coverage
The independent claim covers one core invention: a vacuum-expanded, freeze-dried dry composition for haemostasis and wound healing that spontaneously reconstitutes into a paste on contact with an aqueous medium without mechanical mixing or agitation. Dependent claims further define quantitative constraints, specific excipient selections, specified bioactive agent inclusion, and optional kit/container arrangements.
Vacuum-expanded entrapped-gas dry paste for haemostasis and wound healing
A dry composition suitable for use in haemostasis and wound healing comprising a vacuum-expanded paste having entrapped gas therein, that is subsequently frozen and then freeze-dried, wherein the dry composition upon contact with an aqueous medium is capable of spontaneously reconstituting into a paste without mechanical mixing or agitation.
Freeze-dried paste density range
The dry composition wherein the freeze-dried paste has a paste density between about 1 mg/ml and about 40 mg/ml.
Rapid spontaneous reconstitution without mechanical mixing
The dry composition wherein the dry composition is capable of reconstituting into a paste within less than about 30 seconds.
Thrombin as a bioactive agent
The dry composition wherein the bioactive agent is thrombin.
Mannitol as a sugar alcohol component
The dry composition wherein the one or more sugar alcohols comprises mannitol.
Haemostatic kit with separate dry and aqueous containers
A haemostatic kit comprising a first container with the dry composition and a second container comprising an aqueous medium, and optionally an outer packaging.
Across the independent and dependent claims, the coverage centers on a vacuum-expanded, entrapped-gas paste that is frozen and freeze-dried to produce a dry composition that spontaneously reconstitutes into a paste on aqueous contact without mechanical mixing or agitation, with further narrowing to quantitative density and fast reconstitution criteria and to specific excipient and bioactive agent options such as mannitol and thrombin, plus optional two-container kit formatting.
Stated Advantages
Reduced reconstitution time compared with standard lyophilization
Improved sterility/consistency (as stated in the provided context)
Rapid spontaneous reconstitution upon aqueous addition without mechanical mixing or agitation
Ability to include unstable bioactives such as thrombin (as stated in the provided context)
Reduced OR time/handling (as stated in the provided context)
Documented Applications
Haemostasis using the dry composition that spontaneously reconstitutes into a paste upon contact with an aqueous medium.
Wound healing using the dry composition that spontaneously reconstitutes into a paste upon contact with an aqueous medium.
A haemostatic kit format including a first container with the dry composition and a second container containing an aqueous medium (optionally with outer packaging).
Use in a syringe/vacuum-based reconstitution format involving a vacuum product chamber and vacuum-related channel/valve concepts, as described in the provided context.
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